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Phase II Evaluation of AHCC for the Eradication of HPV Infections (AHCC4HPV)

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Judith A. Smith, The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Judith A. Smith, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02405533
First received: March 17, 2015
Last updated: November 9, 2016
Last verified: November 2016
  Purpose
This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication persistent high risk HPV infection determined by HPV negative test results achieved while on active treatment with AHCC and maintained for 6 month post supplementation and 12 months post completion of AHCC treatment compared to placebo.

Condition Intervention Phase
Human Papilloma Virus Dysplasia CIN1 CIN2 Dietary Supplement: AHCC 3 grams once a day Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-blind, Placebo-controlled Evaluation of AHCC (Active Hexose Correlated Compound) for the Eradication of HPV Infections in Women With HPV Positive Pap Smears

Further study details as provided by Judith A. Smith, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Cervista HPV High Risk Assay [Cervista,(Hologic, Inc., Bedford, MA) [ Time Frame: once every 3 months for 12 months up to 18 months ]
    HPV testing


Secondary Outcome Measures:
  • Immune marker panel [ Time Frame: once every 3 months for 12 months up to 18 months ]
    evaluation of selected immune markers


Estimated Enrollment: 50
Study Start Date: March 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months.
Dietary Supplement: AHCC 3 grams once a day
AHCC supplementation x 6 months with Placebo x 6 months
Other Name: active hexose correlated compound
Placebo Comparator: Group 2
Placebo once a day on an empty stomach x 12 months
Other: Placebo
Placebo supplementation x 12 months

Detailed Description:
This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication HPV infection determined by HPV negative test results achieved while on active treatment with AHCC and maintained for 6 month post supplementation and 12 months post completion of AHCC treatment for Group 1. We will follow all patients for at least 12 months and up to 30 months depending on success of achieving a negative HPV testing results. After receiving AHCC 3 grams x 6 months if positive at the end of 12 months of study treatment, they are considered a treatment failure. If negative after completion of 6 months of AHCC supplementation + 6 months of placebo, they will continue on study for another six months (2 visits) to confirm they remain HPV negative and durable response. Group 2 will serve as untreated control for all time points (end of supplementation, then 6, 9, and 12 months post end of AHCC supplementation.
  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Women over 30 years of age who have a HPV positive test and normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia within three months of study entry.

    • Women must have had 2 other HPV positive tests with normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia

      • 1 greater than 6 months and no more than 18 months prior to study entry
      • 1 greater than 24 months prior to study entry.
    • Women of child bearing potential must have a negative urine pregnancy test within 7 days of therapy start.
    • Patients must have adequate hematologic, renal, and hepatic function as noted from labs within the previous 12 months: ANC >/= 1,500 cells/mm3, platelets 100,000 >/= cells/mm3; Creatinine clearance>/= 60 mL/min (estimated by Cockcroft Gault equation), total bilirubin, SGPT, SGOT, and alkaline phosphatase </= 1.5 times normal.
    • Patients of child-bearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study.

Exclusion Criteria:

  • • History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (> 140/90).

    • Women with a current or prior diagnosis of cancer
    • Women with a current diagnosis of CIN3 cervical dysplasia
    • Women that are pregnant or breast feeding.
    • Women with a history of Hepatitis (autoimmune, A, B, or C) or antigen positive
    • Patients with history of significant psychiatric disorders (schizophrenia, bipolar, psychosis) or uncontrolled seizures.
    • Patients with significant medical co-morbidities at the discretion of the primary Gynecologist. Including immunosuppressive conditions (i.e. HIV+, rheumatoid arthritis, etc) or taking immune modulation mediations (i.e. immunosuppressants)
    • Women that have taken AHCC within the past six months.
    • Women currently taking other immune modulating nutritional supplements.
    • Patients who have undergone a hysterectomy (supracervical hysterectomy allowed)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02405533

Contacts
Contact: Judith A Smith 713-500-6408 Judith.Ann.Smith@uth.tmc.edu

Locations
United States, Texas
UTHealth Medical School at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Judith A Smith, Pharm.D.    713-500-6408    Judith.Ann.Smith@uth.tmc.edu   
Contact: Barbara Rech, RN    713-500-5847    Barbara.Rech@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Study Chair: Judith A Smith, Pharm.D. UTTexas_Houston
  More Information

Responsible Party: Judith A. Smith, Associate Professor & Director of WHIM Research Program, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02405533     History of Changes
Other Study ID Numbers: HSC-MS-14_0866
Study First Received: March 17, 2015
Last Updated: November 9, 2016

Keywords provided by Judith A. Smith, The University of Texas Health Science Center, Houston:
AHCC
nutritional supplement
HPV

Additional relevant MeSH terms:
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 23, 2017